The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users
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|ClinicalTrials.gov Identifier: NCT01814943|
Recruitment Status : Completed
First Posted : March 20, 2013
Last Update Posted : June 18, 2013
This study is conducted in a cohort of low dose aspirin (ASA) users previously ascertained. The aims of the post hoc analyses are:
To estimate the incidence of uncomplicated peptic ulcer (UPU) in a cohort of low-dose ASA for secondary prevention of vascular disease and the relative risk of UPU associated with use and discontinuation of use of low dose ASA.
To estimate the effect of proton pump inhibitors (PPI) on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease To evaluate the effect of other risk factors on the occurrence of UPU among users of low-dose ASA for secondary prevention of vascular disease.
|Condition or disease|
|Uncomplicated Peptic Ulcer|
|Study Type :||Observational|
|Actual Enrollment :||39000 participants|
|Official Title:||The Risk of Uncomplicated Peptic Ulcer in a Cohort of Secondary Prevention Aspirin Users|
|Study Start Date :||November 2012|
|Actual Primary Completion Date :||May 2013|
|Actual Study Completion Date :||May 2013|
|Patients with prescription for low dose ASA (75-300 mg/day)|
- Incidence rates of uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users [ Time Frame: From 1 January 2000 till 30 September 2011, an expected average of 6 years. ]
- Risk (hazard ratio) of developing uncomplicated peptic ulcer in a cohort of secondary prevention aspirin users [ Time Frame: From 1 Januart 2000 till 30 September 2011, an expected average of 6 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01814943
|Principal Investigator:||Luis A Garcia Rodriguez, MD||CEIFE (Centro Espanol de Investigacion Farmacoepidemiologica - Spanish Centre for Pharmacoepidemiologic Research )|